Research Paper

Multiple Sclerosis
15(11) 1329–1338
Reflexology for the treatment of pain ! The Author(s) 2009
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DOI: 10.1177/1352458509345916
msj.sagepub.com
double-blind randomised sham-controlled
clinical trial
CM Hughes1, S Smyth2 and AS Lowe-Strong2

Abstract
Multiple sclerosis (MS) results in pain and other symptoms which may be modified by conventional treatment, however,
MS is still not curable. Several studies have reported positive effects of reflexology in the treatment of pain, however, no
randomised controlled clinical trials for the treatment of pain have been conducted within this population. The objective
of this study was to investigate the effectiveness of reflexology on pain in and MS population. We randomly allocated 73
participants to receive either precision or sham reflexology weekly for 10 weeks. Outcome measures were taken pre-
and post-treatment with follow-up at 6 and 12 weeks by a researcher blinded to group allocation. The primary outcome
measure recorded pain using a Visual Analogue Scale (VAS). A significant (p < 0.0001) and clinically important decrease in
pain intensity was observed in both groups compared with baseline. Median VAS scores were reduced by 50% following
treatment, and maintained for up to 12 weeks. Significant decreases were also observed for fatigue, depression, disability,
spasm and quality of life. In conclusion, precision reflexology was not superior to sham, however, both treatments offer
clinically significant improvements for MS symptoms via a possible placebo effect or stimulation of reflex points in the feet
using non-specific massage.

Keywords
multiple sclerosis, reflexology, pain
Date received: 1st May 2009; accepted: 8th July 2009

Feldenkrais bodywork (1), reflexology (1), magnetic

Introduction
Multiple sclerosis (MS) is a chronic demyelinating neu-
rological disease afflicting young and middle-aged
adults, resulting in problems with coordination,
strength, cognition, and sensation.1 Although treat-
ment with immunomodulatory agents may modify the
course of the disease, MS is still not curable.2,3
Complementary and alternative medicine (CAM) has
become popular for the management of symptoms among
people with MS.4,5 A recent survey6 indicated that 50–
75% of MS patients use CAM, primarily due to the result-
ing improvement in function, decreased symptom sever-
ity7 and dissatisfaction with conventional treatment.4,8
Indeed, 66% of participants in a recent survey5 reported
improvements in their symptoms following CAM.
However, in spite of the popularity of these therapies,
little evidence exists as to their benefits.4,5
The most recent systematic review carried out into
the effectiveness of CAM for the treatment of MS9
included 12 randomised controlled trials (RCTs)
investigating nutritional therapy (4), massage (1),
field therapy (2), neural therapy (1) and psychological
counselling (2). The evidence was not compelling for
any of these therapies, however, many of these trials
contained methodological flaws. Since publication of
this review, Maloni10 reported that Tai Chi, meditation
and hypnotherapy may serve to increase quality of life
and reduce pain in MS. This author stated that CAM
acts to interfere with pain conduction, activates analge-
sia through nociceptive pathways, and raises the pain
threshold.10 A further recent study reported that ginkgo
1
School of Health Sciences, University of Ulster, Shore Road,
Newtownabbey, Northern Ireland.
2
Health and Rehabilitation Sciences Research Institute and School of
Health Sciences, University of Ulster, Shore Road, Newtownabbey,
Northern Ireland.
Corresponding author:
Dr Ciara Hughes, School of Health Sciences, Faculty of Life and Health
Sciences, University of Ulster, Shore Road, Newtownabbey BT37 0QB,
Northern Ireland.
Email: cm.hughes@ulster.ac.uk
1330
biloba exerted beneficial effects on symptom severity
in MS.1
Reflexology is an increasingly popular CAM in
which the massage of zones on the feet corresponds
to different parts of the body.11 A few studies have
examined the effectiveness of reflexology in the form
of RCTs on conditions such as premenstrual syn-
drome,12 asthma,13 irritable bowel syndrome14 and
sinonasal symptoms15 all of which showed some
improvement. In addition, reflexology has been
reported as demonstrating significant improvements
on pain in patients with cancer,16 headache,17 chronic
pain associated with a herniated disc18 and low back
pain.19 However, none of these studies have been fully
powered clinical trials.
In relation to MS, Joyce and Richardson20 demon-
strated a 45% improvement in symptoms associated
with MS including pain, spasm, fatigue, depression
and general well-being following reflexology. However,
only one study to date has investigated the effects of
reflexology on the symptoms of MS in the form of a
RCT,21 which indicated that reflexology was of benefit
in alleviating motor, sensory and urinary symptoms.
There is an overall consensus of opinion in the liter-
ature which recommends that further research is war-
ranted to determine the effects of reflexology in the
form of well conducted RCTs.4,5,9,14 Thus, the main
aim of this paper was to determine the effectiveness of
reflexology on the modification of pain in people with
MS. The benefits of this therapy on other symptoms
and quality of life were also investigated.
Methods
Participants
Ethical approval from the University of Ulster’s
Research Ethical Committee was obtained. We received
148 responses to an advertisement via MS charities and
local advertisement over a 16-month period. Initial
screening included a medical history and pre-trial ques-
tionnaire which recorded participant’s age, time since
diagnosis, disease course and Expanded Disability
Status Scale (EDSS). Inclusion criteria included 18–75
years of age, definite diagnosis of MS, pain greater than
4 on a Visual Analogue Scale (VAS) of at least 2 months
duration and an EDSS of 7.5. Exclusion criteria
included previous experience of reflexology, participa-
tion in research studies currently or within the previous
3 months and relapse (defined as requiring hospitalisa-
tion or steroid treatment) within the past 2 months.
The procedure was explained fully to all participants
and an information sheet was provided. Written
informed consent was obtained from each participant
prior to commencing the study.
Multiple Sclerosis 15(11)
Procedure
Participants were randomly allocated, by an independent
investigator with no other involvement in the trial, accord-
ing to a computer-generated randomised list into either a
Precision Reflexology or Sham Reflexology Group. The
intervention period was for 10 weeks in both groups with
participants attending weekly for treatment and monitor-
ing. Participants were scheduled to attend visits at the
same time of the day to counteract any diurnal variations.
Power calculations were carried out following completion
of the first 20 participants randomised into the trial. These
calculations were based on level of pain as measured via
the VAS (primary outcome measure) and demonstrated
that for 80% power and a standard deviation of 2.8 for a
change of 2 points on the VAS for the two-group study, it
was estimated that 31 participants per group would be
necessary. Furthermore, previous studies investigating
the use of reflexology have reported a loss to follow-up
of between 12.5% (Williamson et al.22) and 17.6%
(Tovey14). Following consultation with a medical statisti-
cian, the loss to follow-up rate in the current study was
predicted to be 15%, therefore at least 71 participants in
total were required to ensure adequate power.
Intervention
Participants in the Precision Reflexology Group
received reflexology involving a sequence of pressure
massage which allowed stimulation of all of the key
reflex points on the feet associated with organs
throughout the body. This system was based on that
developed by Eunice Ingham23,24 whose method is sup-
ported by the International Institute of Reflexology and
is used throughout the western world. Participants in
the Sham Reflexology Group received a standardised
foot massage using the same predefined sequence in
order to provide a sham treatment. This massage used
less pressure (lower level of stimulation to all reflex
points) and included the majority of the reflex areas
on the feet as indicated above. However, the points
which are representative of common areas of pain asso-
ciated with MS25 were avoided. According to reflexol-
ogy theory, this should have had no curative effect on
these areas of pain as no stimulation occurred to these
specific reflexology points.14 As benefits of CAM are
frequently dismissed as a result of increased contact
alone, the main aim of the sham intervention was to
control for such contact.22 Participants in both groups
received treatment for 45 minutes on a weekly basis for
10 consecutive weeks in the participants own home or
at a local venue. All participants were told that they
may or may not experience sensitivity in some areas of
the feet. The duration of the intervention period was
based on results from a previous survey carried out by
Hughes et al.
our research group.26 A reflexologist who was suit-
ably qualified and experienced carried out all treat-
ments for both groups using grapeseed base oil. A
second qualified reflexologist tested for accuracy by
receiving both precision and sham treatments from
the therapist on three occasions throughout the inter-
vention period.
Outcome assessment
Assessments were carried out at baseline (pre-treat-
ment) prior to randomisation and again at week 10
(immediately post-treatment), and further follow-ups
completed at weeks 16 and 22 using valid and reliable
outcome measures by an investigator who was blinded
to group allocation. The primary outcome in this trial
was measurement of pain using a VAS (score 0–10).
Secondary outcome measures included VAS weekly
pain scores (score 0–10), McGill Pain Questionnaire
(MPQ) (Pain Rating Index [PRI] score 0–77; Present
Pain Intensity [PPI] score 0–5),27 the Roland Morris
Disability Questionnaire (score 0–24),28 spasticity
using a VAS (score 0–10), the Multiple Sclerosis
Impact Scale-29 (score 0–100),29 the Modified Fatigue
Impact Scale, (physical score 0–36; cognitive score
0–40; psychosocial score 0–40),30 the Fatigue Severity
Scale (score 1–7),31 the Becks Depression Inventory II
(score 0–63)32 and the Barthel Index (score 0–100).33
Participants were requested to record the use of all
pain medication throughout the duration of the trial.
In addition, a weekly VAS recording pain intensity was
self-completed by each participant throughout the 10
weeks intervention period.
Success of blinding was tested by means of a
questionnaire at week 2 (during treatment) and
week 16 (follow-up) as recommended by Williamson
et al. [22].
Table 1. Demographic details at baseline
Female/male
Age: years mean (SD)
Age range: years
Expanded Disability Status Scale (Mean, SD)
Years since diagnosis: mean (SD)
Type of MS (n)
Benign
Relapsing–Remitting
Primary Progressive
Secondary Progressive
Not known
Level of pain (VAS score: Mean, SD)
1331
Data were analysed using SPSS Version 11.5 statis-
tical package (SPSS, Inc., Chicago, IL, USA). Data
analysis was by intention to treat, was undertaken
before unblinding and included all outliers. In this
study non-parametric statistics were used throughout:
Mann–Whitney U-test for between group differences
and the Wilcoxon Signed Rank test for within group
differences. A p-value of 0.05 was considered signifi-
cant. Baseline data were analysed using t-tests.
Results
One hundred and forty-eight participants were
screened, 70 failed to meet the inclusion criteria and
seven were unwilling to take part in the study; there-
fore, 12 males and 59 females were included in the study
(Figure 1). There were a number of reasons why poten-
tial participants failed to meet the inclusion criteria.
These included changes in medication, pain <4 on the
VAS, currently or previously having received reflexol-
ogy, for geographical reasons (i.e. too far to travel to
treatment centres) and unable to commit to attending
for treatment on a regular basis.
There were no statistically significant differences
between demographic details at baseline between the
two groups (Table 1). In addition, there were no statis-
tically significant differences at baseline for any of the
outcome measures (Table 2). The type of pain described
most often by the participants as their worst pain was
musculoskeletal in origin, most commonly experienced
in the back (28 participants; 15 of which were low back
pain) and legs (19 participants), as well as in the right
leg only (8), left leg only (5), feet (2), shoulders (2), hips
(3), arms (3) and one participant experienced their
worst pain in the eye. Cross tabulations indicated that
there were no significant differences (p > 0.05) in distri-
bution of pain between the two groups.
Precision Reflexology Group Sham Reflexology Group p value
30 females 5 males 29 females 7 males 0.2
50 (11.1) 53 (11.0) 0.9
26–75 34–74
5.8 (0.95) 6.2 (0.8) 0.6
12.9 (8.9) 12.2 (8.4) 0.5
– 1
16 12 0.2
4 4
6 13
9 6
7.5 (1.3) 7.9 (1.5) 0.8
 1332

Table 2. Median values and inter-quartile values at each time point for all outcome measures

Percentage change from

Outcome measure Group allocation Week 1 Week 10 Week 16 Week 22 week 1 to week 10

VAS for pain Sham 8 (7, 9) 4 (1, 8)* 5 (2, 7)* 5 (2, 8)* 50% improvement
Reflexology 8 (7, 9) 4 (2, 6)* 5 (2, 7)* 5 (1, 7)* 50% improvement
McGill Pain Questionnaire Sham 24 (17, 36) 16 (6, 20)* 20 (11, 27)* 22 (14, 33) 33% improvement
PRI Reflexology 20 (16, 28) 13 (8, 21)* 17 (8, 30) 20 (8, 30) 35% improvement
McGill Pain Questionnaire Sham 2 (1, 3) 2 (1, 2) 2 (1, 2) 2 (2, 3) No change
PPI Reflexology 2 (2, 3) 1 (0, 2)*f 2 (1, 3) 2 (1, 2)*f 50% improvement
Roland Morris Disability Sham 7 (0, 14) 1 (0, 5)* 3 (0, 13) 6 (0, 15) 85% improvement
Questionnaire Reflexology 4 (0, 12) 0 (0, 5)* 2 (0, 11) 0 (0, 9) 100% improvement
VAS for Spasm Sham 5 (1, 8) 1 (0, 4)* 3 (0, 6) 3 (0, 5) 80% improvement
Reflexology 6 (1, 8) 1 (0, 5)* 3 (0, 5)* 3 (0, 6)* 83% improvement
MSIS-29 physical Sham 47 (34, 64) 31 (17, 42)* 33 (22, 61)* 42 (38, 55) 34% improvement
Reflexology 44 (23, 61) 26 (12, 43)* 38 (16, 52)* 39 (17, 56) 40% improvement
MSIS-29 psychological Sham 35 (19, 50) 19 (6, 39)* 24 (3, 40)* 31 (14, 45) 46% improvement
Reflexology 36 (15, 49) 14 (6, 25)* 22 (8, 36) 25 (10, 44) 61% improvement
MFIS physical Sham 24 (18, 30) 17 (16, 22)* 20 (15, 24) 21 (18, 26) 29% improvement
Reflexology 24 (16, 27) 16 (9, 22)* 21 (12, 25)* 24 (15, 30) 33% improvement
MFIS cognitive Sham 20 (10, 24) 14 (5, 22)* 13 (4, 18)* 17 (9, 21) 30% improvement
Reflexology 20 (7, 27) 15 (3, 22)* 18 (2, 24)* 17 (6, 28) 25% improvement
MFIS psychological Sham 4 (3, 6) 3 (2, 5)* 4 (1, 5) 4 (4, 6) 25% improvement
Reflexology 4 (2, 6) 2 (1, 4)* 4 (1, 6) 4 (1, 6) 50% improvement
Fatigue Severity Scale Sham 6 (5, 7) 4 (4, 6)* 4 (3, 6)* 5 (4, 6) 33% improvement
Reflexology 5 (4, 6) 4 (2, 5)* 5 (2, 6) 5 (3, 6) 20% improvement
Beck Depression Inventory II Sham 14 (7, 18) 10 (5, 12)* 10 (2, 13)* 12 (4, 16) 29% improvement
Reflexology 12 (5, 20) 6 (3, 10)* 6 (2, 14)* 9 (4, 16) 50% improvement
Barthel Index Sham 88 (75, 95) 90 (88, 95) 86 (79, 95) 85 (75, 90) 2% improvement
Reflexology 90 (80, 95) 95 (85, 100) 95 (85, 100) 95 (85, 100) 5% improvement
Values are median (first, third inter-quartile values).
*Denotes significant change from value obtained at week1.
f
Denotes significant difference between reflexology and placebo intervention.
Multiple Sclerosis 15(11)
Hughes et al.
During the 10 weeks of treatment, two participants
in the Sham Reflexology Group withdrew completely
due to personal circumstances, one participant in the
same group relapsed and one died. One further partic-
ipant in the Sham Reflexology Group relapsed prior to
the week 22 follow-up. Out of the remaining partici-
pants in the trial, treatment compliance was excellent
at 98%, with the majority of participants in both
groups being very pleased with the relief provided and
planned to continue with reflexology following the end
of the trial. There were no adverse incidents as a result
of the treatments employed in either group.
Primary Outcome Measure: VAS (Pain)
At the end of the intervention period (week 10) there
was a significant decrease in pain observed in both
groups when compared with baseline (p < 0.0001)
where a reduction in pain levels of 50% was demon-
strated (Figure 2). However, no statistically significant
differences were found between groups (p = 0.89) at
this time point. This reduction in pain was maintained
at weeks 16 and 22 (p < 0.0001) in both groups. In
addition, the minimally clinical important difference
(MCID) for the VAS has been reported34 to be a
change of greater than 2. This was exceeded by the
end of treatment where both groups demonstrated a
change of 4 points on the scale (Table 2). Table 3 dis-
plays the confidence intervals for the difference in med-
ians between the two groups and highlights that only
small differences exist in scores between the two groups
at each time point.
Secondary Outcome Measures
Weekly VAS (Pain): Weekly pain VAS scores
decreased immediately from baseline and showed a
steady decline throughout the intervention period
(Figure 3). This decrease was found to be significant
in both the Sham Reflexology Group (p = 0.023) and
the Precision Reflexology Group (p = 0.021) by week 2
of treatment. The MCID was achieved by week 3 in the
Precision Reflexology Group and by week 6 in the
Sham Reflexology Group. Although the median VAS
scores for the Precision Reflexology Group were con-
sistently lower than those of the Sham Reflexology
Group, there was no significant difference between
median values on a weekly basis except for week 3
when the Precision Reflexology Group demonstrated
significantly lower pain levels than the Sham
Reflexology Group (p = 0.015).
McGill Pain Questionnaire: PRI. Both groups demon-
strated a significant reduction in pain by week 10
(p = 0.006, Sham Reflexology Group; p = 0.02,
1333
Precision Reflexology Group), however there were no
significant differences between groups (p = 0.6;
Table 2). Al-Smadi35 previously suggested a three-
point difference in the McGill pain questionnaire’s
PRI would indicate a MCID, which was achieved in
both groups by week 10. An increase towards baseline
values by week 22 (p = 0.36, Sham Reflexology Group;
p = 0.44, Precision Reflexology Group) was evident in
both groups.
PPI. Results for the Sham Reflexology Group
remained stable throughout the duration of the trial,
however, a significant reduction was achieved in the
Precision Reflexology Group by week 10 (p < 0.0001);
this reduction was also found to be significantly differ-
ent when compared with the Sham Reflexology Group
(p = 0.012; Table 2).
Roland Morris Disability Questionnaire: Both groups
showed a significant decrease in values by the end of the
treatment period (p = 0.002, Sham Reflexology Group;
p = 0.03, Precision Reflexology Group), thereafter the
Sham Reflexology Group retuned to near baseline
values by week 22 (p = 0.42) whereas the Precision
Reflexology Group remained at a low level although
this was not found to be significant (p = 0.15; Table 2).
VAS (Spasm): Results for both groups demonstrated a
similar statistically significant decrease in spasm by the
end of the treatment period (p = 0.001, Sham
Reflexology Group; p = 0.003, Precision Reflexology
Group) which then increased slightly in both groups
by weeks 16 and 22. However, the results for the
Precision Reflexology Group maintained significance
during this time when compared with baseline
(p  0.003; Table 2).
Multiple Sclerosis Impact Scale-29: Psychological.
Both groups demonstrated a significant reduction by
week 10 (p  0.001) which was maintained to week 16
in the Sham Reflexology Group (p = 0.012). By week
22, however, both groups had increased and were not
found to be statistically significant when compared with
baseline (p  0.17; Table 2).
Physical. By week 10 both groups showed a signifi-
cant decrease in scores, however this reduction was
greater in the Precision Reflexology Group
(p = 0.002, Sham Reflexology Group; p < 0.0001,
Precision Reflexology Group). The observed significant
reductions were maintained to week 16 where again the
Precision Reflexology Group demonstrated the greatest
reduction (p = 0.05, Sham Reflexology Group;
p = 0.025, Precision Reflexology Group). However, at
both of these time points there were no significant dif-
ferences demonstrated between groups (week 10,
p = 0.98; week 16, p = 0.72). At week 22 values had
1334 Multiple Sclerosis 15(11)

Assessed for eligibility (n =148)

Not meeting inclusion

criteria (n =70)
refused to participate
(n =7)

Baseline assessment randomised

(n =71)

Precision reflexology group Sham reflexology group

(n =35) (n=36)

10 weeks intervention

Week 10 assessment (n =32)

Week 10 assessment (n=35) (n =2) withdrew
(n =1) deceased
(n =1) relapsed

Week 16 assessment (n=35) Week 16 assessment (n =32)

Week 22 assessment (n=35) Week 22 assessment (n =31)

(n =1) relapsed

Figure 1. Recruitment and progress of participants through the trial.

increased and were no longer significantly different
from baseline (p  0.5; Table 2).
Modified Fatigue Impact Scale: Physical. Both groups
demonstrated a significant reduction by week 10
(p = 0.003, Sham Reflexology Group; p < 0.0001,
Precision Reflexology Group) which was maintained
to week 16 in the Precision Reflexology Group
(p = 0.014). By week 22, however, both groups had
increased and where no longer found to be statistically
significant when compared with baseline (p = 0.44,
Sham Reflexology Group; p = 1.0, Precision
Reflexology Group: Table 2).
Cognitive. A significant reduction in both groups was
demonstrated by week 10 (p = 0.023, Sham
Reflexology Group; p < 0.0001, Precision Reflexology
Group) which was also maintained to week 16 in
both groups (p = 0.006, Sham Reflexology Group;
Hughes et al. 1335

12 12
∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗ ∗

10 10

Weekly VAS (Pain)

8
6
VAS (pain)

6
4
4
2
2
0

0
Week 1 Week 3 Week 5 Week 7 Week 9
Group Time
Week 1 Week 10 Week 16 Week 22 Sham
Group Time Reflexology
Sham
Reflexology Figure 3. Weekly Visual Analogue Scale scores during inter-
vention (weeks 1–10) for participants according to group allo-
Figure 2. Visual Analogue Scale scores for pain according to cation. Median values are represented by the central black line,
group allocation. Median values are represented by the heavy boxes represent inter-quartile ranges, whiskers represent the
black line, boxes represent inter-quartile ranges, whiskers rep- range of values, ‘o’ represents outliers, ‘*’ represents significant
resent the range of values, ‘o’ represents outliers, ‘*’ represents differences from week 1 (baseline) values (p  0.05).
significant differences from week 1 (baseline) values (p  0.05).
This significant reduction was only maintained to
week 16 in the Sham Reflexology Group (p = 0.003).
Table 3. Median differences between reflexology and sham By week 22, however, both groups had increased to
groups with confidence intervals for Visual Analogue Scale scores baseline values (p  0.14; Table 2).
at each time point

Median difference Confidence intervals Beck Depression Inventory II: Results for both groups
showed a significant reduction in values by week 10
Week 1 0.15 1.12, 0.82 (p = 0.004, Sham Reflexology Group; p = 0.004,
Week 10 0.30 2.03, 2.63 Precision Reflexology Group), which were maintained
Week 16 0.30 2.49, 1.89 by week 16 (p < 0.0001, Sham Reflexology Group;
Week 22 0.00 2.31, 2.31 p = 0.021, Precision Reflexology Group), thereafter
values increased and were no longer significant
(p  0.4; Table 2).

p = 0.018, Precision Reflexology Group). Both groups
where approaching baseline values by the end of the
trial (p  0.41; Table 2).
Psychological. A significant reduction in both groups
was demonstrated by the end of the treatment
period (p = 0.023, Sham Reflexology Group;
p = 0.001, Precision Reflexology Group), however,
both had returned to baseline values by week 16
(p  0.3; Table 2).
Fatigue Severity Scale: Both groups demonstrated a
significant reduction in fatigue by week 10 (p = 0.012,
Sham Reflexology Group; p < 0.0001, Precision
Reflexology Group), however, there were no significant
differences between groups (p = 0.625, Table 2).
Barthel Index: Values in both groups remained
relatively stable throughout the duration of the trial
in both groups (week 10: p = 0.133, Sham
Reflexology Group; p = 0.088, Precision Reflexology
Group, Table 2).
Co-Interventions: There were no trends observed in
the use of pain-relieving medication in either group.
No additional co-interventions were employed by par-
ticipants during the trial period.
Discussion
The main aim of this double-blind sham-controlled
randomised clinical trial was to determine the
1336
effectiveness of reflexology on the modification of pain
in people with MS. The results of this trial have
demonstrated that both precision and sham reflexol-
ogy significantly reduced pain within this neurological
population and, in addition, improved other symp-
toms including quality of life and fatigue with no
adverse effects observed. It is acknowledged that
during the trial the were two relapses and one death,
all of which occurred within the sham group, therefore
due to the fact that these individuals did not receive
precision reflexology, these incidents were not consid-
ered to be as a consequence of the intervention. This
notwithstanding, the beneficial effects observed appear
to be relatively long lasting in that statistically signif-
icant improvements were still observed 3 months after
cessation of treatment.
This is the first study to determine the effectiveness
of reflexology on pain within a MS population and
supports findings within other populations that have
demonstrated a reduction in pain as a result of reflex-
ology.16–19 The most recent of these studies19 also inves-
tigated the effect of precision reflexology compared
with sham treatment in a small group of low back
pain patients and demonstrated a clinically significant
reduction in pain following precision reflexology which
lasted 3 months beyond the intervention period. This
author, however, found no clinical benefit in pain levels
as measured using a VAS as a result of sham treatment;
this is in contrast to our findings which demonstrated a
significant reduction in pain in both groups which may
suggest that the complex array of symptoms associated
with MS may be more responsive to any form of treat-
ment, whether specialised or not.
In the current study, since both groups demonstrated
similar statistically significant beneficial effects in terms
of pain as well as a number of other symptoms, the
question arises as to the physiological process by
which this pain reduction was achieved. If a similar
level of pain reduction can be achieved with sham
reflexology, was the symptomatic relief a placebo
effect, or does it indicate the reflex points on the feet
are not in a specific location?
The placebo effect consists not only of subjective
improvement but also of objective physiological
changes. Numerous studies have been carried out inves-
tigating the healing power of the placebo effect.
A meta-analysis of clinical trials investigating irritable
bowel syndrome has estimated the placebo response as
40.2%.36 Furthermore, a healing rate of 44.2% was
reported following placebo treatment of duodenal
ulcers.37 Other examples include an improvement of
29.7% in the treatment of major depression,38 29.0%
in the treatment of migraine,39 26.8% in the treatment
of reflux esophagitis40 and 19.6% in the treatment of
chronic fatigue syndrome.41
Multiple Sclerosis 15(11)
Biological research has tried to determine what hap-
pens at the biochemical level during the placebo effect.
Hormones, neurotransmitters and other biochemical
agents may be involved in this process and evidence
exists for the role of endorphins and dopamine.42
Placebo analgesia can be blocked by the narcotic antag-
onist naloxone, which supports the idea that placebos
may ease pain by releasing endorphins.43
Previous research suggests that the majority of med-
ical conditions for which patients seek help from CAM
are chronic in nature with a fluctuating course, and
subjective symptoms such as chronic pain, fatigue,
insomnia, anxiety and depression44 all common to
people with MS.2,45 These symptoms are precisely
those which are believed to be susceptible to the pla-
cebo response.44 Shinto et al.46 found that people with
MS report significant benefit from conventional thera-
pies and providers; however, it was suggested that they
may seek CAM for emotional support. By its very
nature CAM provides patient/therapist interactions
and therefore may produce a greater effect than no
treatment at all.47 Indeed several studies have suggested
that the doctor or therapist themselves may be the most
important component of the placebo effect.48,49
In the past a good doctor–patient relationship would
have been considered an important therapeutic tool.50
This interaction with patients resulting in an improve-
ment in the patient’s condition would today be referred
to as the ‘Hawthorne effect’. However, in recent times
we have become increasingly dependent on sophisti-
cated diagnostic tests, high-tech procedures and medi-
cations resulting in little time to develop personal
relationship with patients. Findings from the current
study suggest that there may indeed be measurable
improvements as a result of patient–therapist interac-
tion, above and beyond that provided by any potential
placebo effect.
Sham-controlled trials are often recommended in
order to examine the ‘real effect’ of interventions.
However, this design seems inappropriate whenever
therapist interaction and relaxation are important com-
ponents of the intervention, as with reflexology.
Reflexologists have indicated that a holistic approach
is considered essential in the treatment of chronic
pain.26 In the present study sham reflexology produced
beneficial effects that were as marked as those found
with precision reflexology, as both were found to be
clinically significant. Indeed, Kaptchuk44 asked ‘‘what
should be determined as appropriate healing, the
patient’s improvement from his own baseline (clinical
significance) or a relative improvement compared to a
sham? Are the results less important than the
method?’’. Therefore, a treatment that provides pain
relief, even though it may be attributed in part to a
placebo effect, would be useful.
Hughes et al.
As stated earlier, another theory to explain the ben-
eficial effects observed in both groups may be that the
reflex points on the feet are not in as specific a location
as suggested previously. Stimulation in the general area
may cause an effect. Indeed research into the accuracy
of reflexology charts indicates that reflexologists were
not able to determine the presence of pathology accord-
ing to reflex points. This would indicate that the reflex
points were not specifically associated with one area of
the body.51 However, reflexologists do not claim to
diagnose disease and therefore whether they can deter-
mine the presence of a disease through the feet
may have no relation to the healing capabilities of
the therapy. This may, however, explain the results of
the present study where a general foot massage may
have stimulated reflex points and therefore induced
healing.
In terms of financial implications, in 2006 Kobelt
et al.47 assessed the overall resource consumption for
people with MS in nine European countries by inter-
viewing 13,186 patients enrolled in national MS socie-
ties or followed up in neurology clinics. The total mean
annual costs per individual were estimated at E18,000
for mild disease (EDSS <4.0), E36,500 for moderate
disease (EDSS 4.0–6.5) and E62,000 for severe disease
(EDSS >7.0); therefore, the financial burden is high.
Furthermore, in the present study many of the partici-
pants had expressed dissatisfaction with conventional
treatment provided for pain; indeed in population sur-
veys this is often the reason people give for turning to
CAM.52
Results from the current study clearly demonstrate
a statistically significant and clinically significant
reduction in pain following precision reflexology
and sham reflexology within the study population.
In addition, the observed reduction in pain continued
for a further 10 weeks beyond the intervention
period. In the group receiving precision reflexology
a clinically important reduction in pain was evident
by the third session, which is in keeping with findings
from a previous survey, which indicated that approx-
imately six treatments are required to achieve relief
from back pain.26 Not only did both treatments pro-
vide relief from pain, but also resulted in a reduction
in other symptoms related to MS including fatigue,
depression, disability and muscle spasm. This study
has indicated that precision reflexology is not supe-
rior to sham reflexology. However, both treatments
offer clinically significant improvements for symptoms
associated with MS. The improvements observed fol-
lowing the sham reflexology may be explained by a
possible placebo effect or the stimulation of reflex
points in the feet using non-specific massage. Thus,
the mechanism of action of reflexology requires fur-
ther investigation.
1337
Acknowledgements
We would like to gratefully acknowledge financial support
from the National Multiple Sclerosis Society, USA, Action
MS for their assistance with recruitment and the use of facil-
ities, Ian Bradbury and Evie Gardener for statistical advice
and Catherine Adams for assistance with data collection.
There are no conflicts of interest associated with the publica-
tion of this study.
References
1. Johnston SK, Diamond BJ, Raush S, Shiflet SC, Graves
L. The effect of Ginkgo Biloba on functional measures in
multiple sclerosis: a pilot randomised controlled trial.
Explore (NY) 2006; 2: 19–24.
2. Blevins G, Martin R. Future immunotherapies in multi-
ple sclerosis. Semin Neurol 2003; 23: 147–158.
3. Neuhaus O, Archelos JJ, Hartung HP.
Immunomodulation in multiple sclerosis: from immuno-
suppression to neuroprotection. Trends Pharmacol Sci
2003; 24: 131–138.
4. Nayak S, Matheis RJ, Schoenberger NE, Shiflett SC. Use
of unconventional therapies by individuals with multiple
sclerosis. Clin Rehabil 2003; 17: 181–191.
5. Apel A, Greim B, Zettl UK. How frequently do patients
with multiple sclerosis use complementary and alternative
medicine? Comp Ther Med 2005; 13: 258–263.
6. Murray TJ. Complementary and alternative medicine for
MS. Int MS J 2006; 13: 3.
7. Fawcett J, Seliger Sidney J, Riley-Lawless K, Hanson
MJ. An exploratory study of the relationship between
alternative therapies, functional status, and symptom
severity among people with multiple sclerosis. J Holistic
Nursing 1996; 14: 115–129.
8. Carlson MJ, Krahn G. Use of complementary and alter-
native medicine practitioners by people with physical dis-
abilities: estimates from a National US Survey. Disabil
Rehabil 2006; 28: 505–513.
9. Huntley A, Ernst E. Complementary and alternative
therapies for treating multiple sclerosis symptoms: a sys-
tematic review. Comp Ther Med 2000; 8: 97–105.
10. Maloni H. Pain in multiple sclerosis: an overview of its
nature and management. J Neurosci Nurs 2000; 32:
139–144.
11. McDonough S, Devine P, Baxter D. Complementary and
alternative medicine: patterns of use in Northern Ireland.
Northern Ireland Life and Times Survey 2005; 50. www.ark.
ac.uk/publications/updates/update50.pdf. Accessed online
July 2009.
12. Stevinson C, Ernst E. Complementary/alternative thera-
pies for premenstrual syndrome: a systematic review of
randomized controlled trials. Am J Obstet Gynecol 2001;
185: 227–235.
13. Brygge T, Heinig JH, Collins P, et al. Reflexology and
bronchial asthma. Respir Med 2001; 95: 173–179.
14. Tovey P. A single-blind trial of reflexology for irritable
bowel syndrome. Br J Gen Pract 2002; 52(474): 19–23.
15. Heatley DG, McConnell KE, Kille TL, Leverson GE.
Nasal irrigation for the alleviation of sinonasal symp-
toms. Otolaryngol Head Neck Surg 2001; 125: 44–48.
1338
16. Stephenson NL, Weinrich SP, Tavakoli AS. The effects
of foot reflexology on anxiety and pain in patients with
breast and lung cancer. Oncol Nurs Forum 2000; 27:
67–72.
17. Launsø L, Brendstrup E, Arnberg S. An exploratory
study of reflexological treatment for headache. Altern
Ther Health Med 1999; 5: 57–65.
18. Degan M, Fabris F, Vanin F, et al. The effectiveness of
foot reflexotherapy on chronic pain associated with a
herniated disk. Prof Inferm 2000; 53: 80–87.
19. Quinn F, Baxter GD, Hughes C. Reflexology in the man-
agement of low back pain: a pilot study of effectiveness.
Comp Ther Med 2007; 16: 3–8.
20. Joyce M, Richardson R. Reflexology can help MS. Int J
Alternat Complem Med 1997; 15: 10–12.
21. Siev-Ner I, Gamus D, Lerner-Geva L, Achiron A.
Reflexology treatment relieves symptoms of multiple
sclerosis: a randomized controlled study. Mult Scler
2003; 9: 356–361.
22. Williamson J, White A, Hart A, Ernst E. Randomised
controlled trial of reflexology for menopausal women.
Int J Obs Gynae 2002; 109: 1050–1055.
23. Ingham E, Byres D. Stories the feet can tell have told
through reflexology. Ingham Publishing Inc., 1984.
24. Byres D. Better health with foot reflexology. Ingham
Publishing Inc., 2001.
25. Ehde DM, Osborne TL, Hanley MA, Jensen MP, Kraft
GH. The scope and nature of pain in persons with mul-
tiple sclerosis. Mult Scler 2006; 12: 629–638.
26. Quinn F, Baxter GD, Hughes C. Complementary thera-
pies in the management of low back pain: a survey of
reflexologists. Comp Ther Med 2007; 16: 9–14.
27. Melzack R. The McGill Pain Questionnaire: Major prop-
erties and Scoring methods. Pain 1975; 1: 277–299.
28. Roland M, Morris R. A study of the natural history of
back pain. Part 1: Development of a reliable and sensitive
measure of disability in back pain. Spine 1983; 8:
141–144.
29. Hobart J, Lamping D, Fitzpatrick R, Riazi A, Thompson
A. The Multiple Sclerosis Impact Scale (MSIS-29): a new
patient-based outcome measure. Brain 2001; 124:
962–973.
30. Multiple Sclerosis Council for Clinical Practice
Guidelines. Fatigue and multiple sclerosis: evidence-based
management strategies for fatigue in multiple sclerosis.
Washington, DC: Paralyzed Veterans of America, 1998,
pp. 1–33.
31. Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD.
The fatigue severity scale. Application to patients with
multiple sclerosis and systemic lupus erythematosus.
Arch Neurol 1989; 46: 1121–1123.
32. Beck AT, Steer RA, Ball R, Ranieri WF. Comparison of
Beck Depression Inventories -IA and -II in Psychiatric
Outpatients. J Personality Assess 1996; 67: 588–597.
33. Mahoney FI, Barthel DW. Function evaluation: the
Barthel Index. Maryland State Med J 1965; 14: 61–65.
34. Farrar JT, Young Jr JP, LaMoreaux L, Werth JL, Poole
RM. Clinical importance of changes in chronic pain
intensity measured on an 11-point numerical pain rating
scale. Pain 2001; 94: 149–158.
Multiple Sclerosis 15(11)
35. Al-Smadi J. The conservative management of the signs and
symptoms of multiple sclerosis. PhD Thesis, University of
Ulster, 2004.
36. Patel SM, Stason WB, Legedza A, et al. The placebo
effect in irritable bowel syndrome trials: a meta-analysis.
Neurogastroenterol Motil 2005; 17: 332–340.
37. de Craen AJ, Moerman DE, Heisterkamp SH, Tytgat
GN, Tijssen JG, Kleijnen J. Placebo effect in the treat-
ment of duodenal ulcer. Br J Clin Pharmacol 1999; 48:
853–860.
38. Walsh BT, Seidman SN, Sysko R, Gould M. Placebo
response in studies of major depression: variable, sub-
stantial, and growing. JAMA 2002; 287: 1840–1847.
39. de Craen AJ, Tijssen JG, de Gans J, Kleijnen J. Placebo
effect in the acute treatment of migraine: subcutaneous
placebos are better than oral placebos. J Neurol 2000;
247: 183–188.
40. Pace F, Maconi G, Molteni P, Minguzzi M, Bianchi
Porro G. Meta-analysis of the effect of placebo on the
outcome of medically treated reflux esophagitis. Scand J
Gastroenterol 1995; 30: 101–105.
41. Cho HJ, Hotopf M, Wessely S. The placebo response in
the treatment of chronic fatigue syndrome: a systematic
review and meta-analysis. Psychosom Med 2005; 67:
301–313.
42. Thompson WG. The placebo effect and health–combining
science and compassionate care. Amherst, NY: Prome-
theus Books, 2005.
43. Rowbotham DJ. Endogenous opioids, placebo response,
and pain. Lancet 2001; 357(9272): 1901–1902.
44. Kaptchuk TJ. The placebo effect in Alternative medicine:
can performance of a healing ritual have clinical signifi-
cance? Ann Intern Med 2002; 136: 817–825.
45. Beiske AG, Svensson E, Sandanger I, et al. Depression
and anxiety amongst multiple sclerosis patients. Europ J
Neurol 2008; 15: 239–245.
46. Shinto L, Yadav V, Morris C, Lapidus JA, Senders A,
Bourdette D. The perceived benefit and satisfaction from
conventional and complementary and alternative medi-
cine (CAM) in people with multiple sclerosis. Comp
Ther Med 2005; 13: 264–272.
47. Kobelt G, Berg J, Lindgren P, Fredrikson S, Jonsson
B. Costs and quality of life of patients with multiple
sclerosis in Europe. J Neurol Neurosur Psych 2006; 77:
918–926.
48. Thomas KB. General practice consultations: is there any
point in being positive? Br Med J (Clin Res Ed) 1987;
294(6581): 1200–1202.
49. Vase L, Robinson ME, Verne GN, Price DD. The con-
tributions of suggestion, desire, and expectation to pla-
cebo effects in irritable bowel syndrome patients. An
empirical investigation. Pain 2003; 105: 17–25.
50. Cho HJ. Reviving the old sermon of medicine with the
placebo effect. Rev Bras Psiquiatr 2005; 27: 336–340.
51. White AR, Williamson J, Hart A, Ernst E. A blinded
investigation into the accuracy of reflexology charts.
Comp Ther Med 2000; 8: 166–172.
52. Vincent C, Furnham A. Why do patients turn to comple-
mentary medicine? An empirical study. Br J Clin Psychol
1996; 35: 37–48.